Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)

NCT04018001 | Completed Results

• 1 other identifier: A3921349
• Study Type: observational
• Target: 1,057
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare adherence, persistence, and effectiveness among patients initiating tofacitinib Modified Release (MR) with tofacitinib Immediate Release (IR).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date

  Effectiveness criteria: 1) High adherence with proportion of days covered greater than or equal to \[\>=\] 0.8; 2) No increase in index medication dose; 3) No use of an advanced therapy other than index therapy 4) No addition/claims of conventional synthetic disease-modifying antirheumatic drug; 5) If no oral glucocorticoid prescriptions in the 6 months prior to index date, then no more than 30 total days supply of oral glucocorticoids between 3-12 months post index or if at least 1 claim for oral glucocorticoids during 6 months pre-index, then oral glucocorticoid not increased by \>=20% between 6-12 months post-index compared to 6 months before index date (6) Participants have one or fewer glucocorticoid injections during 3-12 months after index date. Adherence was defined as percentage of time with medication on hand. Participants who met all 6 effectiveness criteria considered as treated effectively.

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

• Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date

  Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

• Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date

  Adherence was defined as percentage of time with medication on hand. Participants with MPR \>=0.8 were considered to show high adherence and participants with MPR less than (\<) 0.8 were considered as low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

• Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 12 Months From the Index Date

  Adherence is defined as percentage of time with medication on hand. Participants with MPR \>=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

• Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date

  Adherence was defined as percentage of time with medication on hand. Participants with PDC \>= 0.8 were considered to show high adherence and participants with PDC \<0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

• Primary: Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date

  Adherence was defined as percentage of time with medication on hand. Participants with PDC \>=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

Secondary Outcomes (5)

• Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date

  Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

• Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date

  Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

• Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 6 Months From the Index Date

  Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

• Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date

  Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

• Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date

  Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

Other Outcomes (2)

• Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date

  Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

• Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date

  Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

Study Arms (1)

Truven Health MarketScan Research Database

individuals who are privately insured and with Medicare Supplemental insurance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals initiating tofacitinib

You may qualify if:

• At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period).
• Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x \& 714.81 or ICD10 = M05.\* \& M06.0\*-M06.3\* or M06.8\*-M06.9\*.
• At least 18 years old as of the index date.

You may not qualify if:

• Patients with claims for other conditions for which biologics are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
• Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with other biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) \[adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)\] and non-TNFi's with alternative mechanisms of action \[abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)\]) during the one-year pre-index period.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10017, United States

Location

Related Publications (1)

• Cohen SB, Greenberg JD, Harnett J, Madsen A, Smith TW, Gruben D, Zhang R, Lukic T, Woolcott J, Dandreo KJ, Litman HJ, Blachley T, Lenihan A, Chen C, Rivas JL, Dougados M. Real-World Evidence to Contextualize Clinical Trial Results and Inform Regulatory Decisions: Tofacitinib Modified-Release Once-Daily vs Immediate-Release Twice-Daily for Rheumatoid Arthritis. Adv Ther. 2021 Jan;38(1):226-248. doi: 10.1007/s12325-020-01501-z. Epub 2020 Oct 9.

  PMID: 33034006 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 12, 2019
• Study Start: April 12, 2019
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: April 3, 2024
• Results First Posted: April 10, 2020

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)